Status:
TERMINATED
The Effect of Donepezil on Sedation and Other Symptoms
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Pfizer
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary Objective: 1\. To determine the effectiveness of donepezil as compared to placebo for the management of opiate-induced sedation/drowsiness in patients with stable cancer pain Secondary Objec...
Detailed Description
Donepezil is currently used in the treatment of certain types of mental disorders, including Alzheimer's disease. Recent research studies have shown that donepezil helps to improve drowsiness in cance...
Eligibility Criteria
Inclusion
- Patient with drowsiness/sedation caused by opiate for \> 3 days and its intensity more or equal to 3/10 (0 to 10 scale; 0 = no sedation, 10=worst possible sedation).
- Patient receiving a regular dose of a strong opioid for the treatment of cancer pain, and no dose changes or dose change within 50% for at least 48 hours.Regular administration, defined as short acting opioids oral or parenteral every 4 hours around clock, slow release oral opioids every 12 hs or 24 hs, or transdermal opioids every 72 hours. Strong opioids include morphine, hydromorphone, methadone, fentanyl, and oxycodone.
- Patient with relatively intact cognition defined by the Mini Mental State Examination according to age and educational level. A score of 24 or above is usually considered normal.
- Patient willing to engage in follow up visit with a nurse by phone on day 2-7 (each day), 11 and 15 of the study and to return for follow up visit on day 8 of treatment. If patient is unable to come to clinic, assessment will be performed through telephone.
- Sexually active females at risk of being pregnant with a negative urine pregnancy test
- Written consent form signed.
- Patients are 18 years or older
- Concurrent radiation treatment (defined as 10 or less fractions for a palliative indication) is allowed
- Concurrent chemotherapy is allowed, if the first two cycles have been well tolerated (defined as no grade 3 or 4 non-hematological toxicity)
Exclusion
- Major contraindication to donepezil i.e. hypersensitivity to donepezil or piperidine derivatives.
- Patients in whom a major change in opiate dose, analgesia requirements, anesthetic procedures or general anesthetic is expected over the next seven days.
- Treatment with anti-cholinergic agents (i.e., glycopyrrolate)
- Patients taking Methylphenidate.
- Patients with tube feeding (due to difficulty of accurate assessing some of the symptoms such as appetite and anorexia).
- History of ongoing arrhythmia causing a rhythm other than a sinus rhythm
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00352664
Start Date
November 1 2003
End Date
July 1 2007
Last Update
May 9 2016
Active Locations (1)
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1
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030